ANDA 208776

TARO

FDA Drug Application

Application #208776

Application Sponsors

ANDA 208776

TARO

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

5%;EQ 1% BASE

0

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-05-25

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208776
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE","activeIngredients":"BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE","strength":"5%;EQ 1% BASE","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/25\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-25
        )

)